BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TSolution One w/ACG surgical System

    K Number: K150741 · Decision Oct 22, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    22
    Review Days
    213

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    Basic Information

    Device Name
    TSolution One w/ACG surgical System
    K Number
    K150741
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    THINK Surgical, Inc.
    Date Received
    March 23, 2015
    Decision Date
    October 22, 2015
    Product Code
    OJP
    Advisory Committee
    Neurology
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OJP Orthopedic Computer Controlled Surgical System

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